The purpose of this study is to monitor the safety of the medications used in the preterm labor study by collecting information on the health and development of the child after child’s mother participated in a retosiban study for preterm labor during the child’s mother’s pregnancy.

Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies - Follow-Up Study to Assess Long-Term Safety of Infants and Children exposed to Retosiban

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000499-24-BE

Enrollment

330

Registered

2014-11-14

Start date

2015-02-16

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preterm labour and improve neonatal health MedDRA version: 20.1 Level: PT Classification code 10036595 Term: Premature delivery System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Product Name: Retosiban Product Code: GSK221149 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Retosiban CAS Number: 820957-38-8 Current Sponsor code: GSK221149A Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants eligible for enrollment in the study must meet all of the following criteria: 1.Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III retosiban clinical studies. 2.Infant is alive at 28 days post EDD. 3.Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of participants aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements. Are the trial subjects under 18? yes Number of subjects for this age range: 330 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: All infants who meet the inclusion criteria will be eligible to enroll in the study. There are no formal exclusion criteria for participation.

Design outcomes

Primary

Measure	Time frame
Main Objective: The study objective is to assess the safety and outcomes in infants and children who were exposed to retosiban or comparator in the Phase III treatment studiess. Specific objectives include the following: •To characterize the clinical safety in terms of infant and children morbidity and mortality in infants and children exposed to retosiban or comparator in utero •To characterize the clinical safety in terms of neurodevelopment in infants and children exposed to retosiban or comparator in utero •To characterize parental productivity loss related to a sick child and infant resource utilization in terms of hospital admissions, length of stay, emergency room/urgent care (ER/UC) visits, surgical procedures, and referral to specialty care or therapy visits for infants (up to age 2 years) exposed to retosiban or comparator in utero ;Secondary Objective: Not Applicable;Primary end point(s): Morbidity and mortality endpoints: •Proportion of infants and children with newly diagnosed (after 28 days post EDD) chronic medical conditions by type of condition will be recorded and include the following: •Respiratory conditions •Neurological conditions •Sensory conditions •Gastrointestinal conditions •Cardiovascular conditions •Renal conditions •Growth parameters •Proportion of infants and children with newly diagnosed (after 28 days post EDD) congenital anomalies •Proportion of infant and child deaths after 28 days post EDD and until 24 months chronological age;Timepoint(s) of evaluation of this end point: collection of neonatal morbidity data and will occur at 28 days after the estimated date of delivery (EDD) and the infant's parent/legal guardian will be asked to complete a Child Health Inventory at 2, 6, 9, 12, 15, 18, 21, and 24 months of the child’s chronological age	—

Measure

Time frame

Main Objective: The study objective is to assess the safety and outcomes in infants and children who were exposed to retosiban or comparator in the Phase III treatment studiess. Specific objectives include the following: •To characterize the clinical safety in terms of infant and children morbidity and mortality in infants and children exposed to retosiban or comparator in utero •To characterize the clinical safety in terms of neurodevelopment in infants and children exposed to retosiban or comparator in utero •To characterize parental productivity loss related to a sick child and infant resource utilization in terms of hospital admissions, length of stay, emergency room/urgent care (ER/UC) visits, surgical procedures, and referral to specialty care or therapy visits for infants (up to age 2 years) exposed to retosiban or comparator in utero ;Secondary Objective: Not Applicable;Primary end point(s): Morbidity and mortality endpoints: •Proportion of infants and children with newly diagnosed (after 28 days post EDD) chronic medical conditions by type of condition will be recorded and include the following: •Respiratory conditions •Neurological conditions •Sensory conditions •Gastrointestinal conditions •Cardiovascular conditions •Renal conditions •Growth parameters •Proportion of infants and children with newly diagnosed (after 28 days post EDD) congenital anomalies •Proportion of infant and child deaths after 28 days post EDD and until 24 months chronological age;Timepoint(s) of evaluation of this end point: collection of neonatal morbidity data and will occur at 28 days after the estimated date of delivery (EDD) and the infant's parent/legal guardian will be asked to complete a Child Health Inventory at 2, 6, 9, 12, 15, 18, 21, and 24 months of the child’s chronological age

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Secondary

Measure	Time frame
Secondary end point(s): Neurodevelopment endpoints: •Neurodevelopment endpoints assessed at ages 9, 18, and 24 months, corrected for prematurity: •Proportion of infants with an ASQ-3 score in the black zone in any domain •Proportion of infants with an ASQ-3 score in the black zone for gross motor skills •Proportion of infants with an ASQ-3 score in the black zone for fine motor skills •Proportion of infants with an ASQ-3 score in the black zone for communication •Proportion of infants with an ASQ-3 score in the black zone for problem solving •Proportion of infants with an ASQ-3 score in the black zone for personal-social skills •Proportion of infants referred for developmental evaluation (using BSID III) •Proportion of infants with a BSID-III score >2 SDs below the mean score for the cognitive impairment (2 SDs below the mean score for the gross motor scale (2 SDs below the mean score for the fine motor scale (2 SDs below the mean score for the language scale (2 SDs below mean score (2 SDs below mean score (<70) (at 24 months corrected age) •Diagnosis of ASD, attention deficit disorder (ADD), or attention deficit hyperactivity disorder (ADHD) Exploratory resource utilization endpoints include: •Number of hospital admissions, proportion of infants and children with any hospital admission, post-birth hospitalization discharge, by principal and secondary discharge diagnosis, type of hospital unit admitted to (e.g., neonatal intensive care unit, [NICU], Pediatric, pediatric intensive care unit [PICU], Nursery level 3, intensive care unit [ICU)]), and length of hospital stay per unit after 28 days post EDD and until 24 months chronological age. •Combined length of hospital stay in days for all hospital admissions (for infants discharged from the delivery hospitalization and for babies who were never discharged home post-delivery) after 28 days post EDD and 24 months chronological age. •Number of surgical procedures (details of type and whether performed on	—

Measure

Time frame

Secondary end point(s): Neurodevelopment endpoints: •Neurodevelopment endpoints assessed at ages 9, 18, and 24 months, corrected for prematurity: •Proportion of infants with an ASQ-3 score in the black zone in any domain •Proportion of infants with an ASQ-3 score in the black zone for gross motor skills •Proportion of infants with an ASQ-3 score in the black zone for fine motor skills •Proportion of infants with an ASQ-3 score in the black zone for communication •Proportion of infants with an ASQ-3 score in the black zone for problem solving •Proportion of infants with an ASQ-3 score in the black zone for personal-social skills •Proportion of infants referred for developmental evaluation (using BSID III) •Proportion of infants with a BSID-III score >2 SDs below the mean score for the cognitive impairment (2 SDs below the mean score for the gross motor scale (2 SDs below the mean score for the fine motor scale (2 SDs below the mean score for the language scale (2 SDs below mean score (2 SDs below mean score (<70) (at 24 months corrected age) •Diagnosis of ASD, attention deficit disorder (ADD), or attention deficit hyperactivity disorder (ADHD) Exploratory resource utilization endpoints include: •Number of hospital admissions, proportion of infants and children with any hospital admission, post-birth hospitalization discharge, by principal and secondary discharge diagnosis, type of hospital unit admitted to (e.g., neonatal intensive care unit, [NICU], Pediatric, pediatric intensive care unit [PICU], Nursery level 3, intensive care unit [ICU)]), and length of hospital stay per unit after 28 days post EDD and until 24 months chronological age. •Combined length of hospital stay in days for all hospital admissions (for infants discharged from the delivery hospitalization and for babies who were never discharged home post-delivery) after 28 days post EDD and 24 months chronological age. •Number of surgical procedures (details of type and whether performed on

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Countries

Belgium, France, Germany, Israel, Italy, Korea, Republic of, Mexico, Spain, Sweden, United Kingdom

Contacts

Public ContactRobert Stocken

GlaxoSmithKline Research & Development Limited

robert.c.stocken@gsk.com00442089903879

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026